Reprocessed
LigaSure Impact™ Curved, Large Jaw, Open Sealer/Dividers
Page 2 of 16
Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Dividers Description
The Reprocessed LigaSure Impact
TM
Curved, Large Jaw, Open Sealer / Divider (LF4318) is a hand-held bipolar electrosurgical
instrument designed for use with Covidien electrosurgical generators that include vessel sealing capability. Please refer to the
cover page for details on compatible generator models and software versions. If the software version on your generator is
lower than required, contact Covidien about software upgrades.
The instrument has a shaft diameter of 13.5 mm (square), shaft length of 18 cm, and a jaw length of 36 mm. The following
controls are located on the instrument handle:
•
A lever for opening and closing the instrument jaws. The mechanism incorporates a latch to hold the jaws in the
closed position during vessel sealing and cutting.
•
An activation button for generator power to initiate vessel sealing.
•
A trigger for actuating the cutter.
•
A knob to rotate the instrument jaws.
All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or
utilizing a footswitch connected to the generator.
Maximum rated voltage: 288 V
peak
Indications for Use
The Reprocessed LigaSure Impact
TM
Curved, Large Jaw, Open Sealer / Divider (LF4318) is a dedicated bipolar electrosurgical
instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LF4318 is
intended to be used with the Covidien electrosurgical generators that include vessel sealing capability to cut and seal vessels,
and to cut, grasp, and dissect tissue during surgery. The indications for use include open procedures (general, urologic,
vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal
hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LF4318 can be used on vessels
(arteries, veins, pulmonary vasculature, and lymph) up to and including 7 mm and tissue bundles.
The LigaSure
TM
system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization
procedures. Do not use the LigaSure
TM
system for these procedures.
Contraindications for Use
Reprocessed
LigaSure Impact™ Curved, Large Jaw, Open Sealer/Dividers Description
are contraindicated for:
•
None
Warnings
•
The LF4318 instrument is intended for use ONLY with the equipment listed on the cover of this document. Use of this
instrument with other generators may not result in the desired tissue effect, may result in injury to the patient or surgical
team, or may cause damage to the instrument.
•
Do not use the LigaSure System unless properly trained to use it in the specific procedure being undertaken. Use of this
equipment without such training may result in serious unintended patient injury.
•
Use caution during surgical cases in which patients exhibit certain types of vascular pathology (atherosclerosis,
aneurysmal vessels, etc.). For best results, apply the seal to unaffected vasculature.
•
Do not use this instrument on vessels in excess of 7 mm in diameter.
•
These instruments are only intended for use by individuals with adequate training and familiarity with the specific
procedure being undertaken. Use of this equipment without such training may result in serious unintended patient injury.
For further information about techniques, complications and hazards, consult the medical literature.
•
Package is provided sterile by method of ethylene oxide gas and is for single patient use only. Do not use if there is any
evidence of damage to the package.
